Trial Information

Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma

OBJECTIVES:

- Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and
total-body irradiation followed by allogeneic hematopoietic stem cell transplantation,
in terms of 6-month and 12-month response rate, in patients with unresectable
metastatic renal cell carcinoma.

OUTLINE:

- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2
and total-body irradiation (TBI) on day 0.

- Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo
AHSCT on day 0.

- Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56
followed by a taper until day 81. Patients also receive oral mycophenolate mofetil
twice daily on days 0-27 (if patient has a related donor) OR three times daily on days
0-29 and then twice daily on days 30-149 followed by additional tapering until day 180
(if patient has an unrelated donor).

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.